Big Molecule Watch
April 3, 2019

Lupin’s Etanercept Biosimilar Gains Approval in Japan

Lupin recently announced approval in Japan to manufacture and sell an etanercept biosimilar, YLB113.  YLB113 is approved to treat moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis.  YLB113 will be marketed in Japan by a joint venture between YL Biologics Limited and a Lupin subsidiary.  This marks Lupin’s first biosimilar to be marketed in Japan, and follows Mochida Pharmaceutical and LG Chem’s etanercept biosimilar that received approval from the Japanese Ministry of Health, Labour and Welfare in January 2018.

The biosimilar YLB113 is manufactured at Lupin Biotech facilities in Pune, India which was inspected and approved by the Pharmaceuticals and Medical Devices Agency.  Lupin stated that this facility was also inspected and approved for European Good Manufacturing Practices certification, which Lupin Biotech facility says “is a major step in achieving our goal for market entry in to Europe post approval of our [etanercept] product.”

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